At a glance
- Melphalan flufenamide (melflufen) is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 81 publications mentioning it, including 3 randomized controlled trials and 2 animal-only studies.
- ClinicalTrials.gov lists 11 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 113 reports mentioning it; 79 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Tumor-homing peptides in precision oncology.
- Comment on "Exceptional long-term responses from OCEAN and HORIZON trials: melflufen-dexamethasone as an expansion of treatment options for relapsed/refractory multiple myeloma in the era of new immunotherapies?".
- Peptide-Drug Conjugates for Targeted Delivery in Hematological Malignancies: From Design Principles to Clinical Application.
- Real-World Outcomes of Melflufen Plus Dexamethasone in Heavily Pretreated Relapsed/Refractory Multiple Myeloma After Exposure to Immunotherapies.
- BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function.
- Melflufen in Multiple Myeloma: Clinical Limitations, Biological Rationale, and Future Perspectives.
- Positioning of Melflufen in Heavily Pretreated RRMM Patients: Real-World Evidence in a Rapidly Evolving Therapeutic Landscape.
- Tumor Targeting with Peptide-Drug Conjugates: Showcasing Key Progress and Hurdles.
- Efficacy of melflufen in multiple myeloma with mutated or deleted TP53.
- Optimizing the use of melflufen (melphalan flufenamide) in relapsed or refractory multiple myeloma: recommendations for clinical practice.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 11
- Active
- 1
- With posted results
- 7
Conditions studied
Show 1 more study
| Study | Status | Phase | Start |
|---|---|---|---|
| Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma | Approved for marketing | — | — |
All 11 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 113
- Serious
- 79
- With death outcome
- 30
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.